Catalog Number 328411 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe had the hub separate from the device.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe had the hub separate from the device.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 23-jan-2024.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe had the hub separate from the device.The following information was provided by the initial reporter: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
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Search Alerts/Recalls
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